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Alina Approval and Balda Divestiture: Stevanato Sharpens Its Focus on High-Value Biologics

With a landmark drug delivery approval and a low-margin divestiture, the company pivots decisively toward proprietary, integrated solutions.
STVN · Earnings Call · 2026-08-04

A Milestone for Proprietary Devices

Stevanato Group's second-quarter report was headlined by a landmark regulatory approval. The company's proprietary Alina variable-dose pen platform received European approval for a liraglutide-based therapy, covering both diabetes and weight management indications. Franco Stevanato, Chairman and CEO, framed this as a transformative event for the company's positioning:

The fact that now we were validated in Europe in many countries for this Alina product, both for diabetes and for weight loss management treatment, is going to recognize that Stevanato today plays in what we so-call Champions League because we are not serving any more the product through the CMO business model, but we are serving our IP product.

Franco Stevanato, Chairman and Chief Executive Officer · 2026-08-04

This approval validates an eight-year development effort and accelerates traction with biosimilar customers. Management noted that revenue from Alina is already embedded in 2026 guidance and expects IP product sales to grow double-digit next year. The drug delivery system strategy is further backed by the introduction of Deora, a new fixed-dose pen, and the expansion of manufacturing in Germany.

Franco later added, "The revenue around Alina already captured in our guidance 2026, and most probably, in the next year to come, Alina will generate double-digit revenue growth" “(same call)” — Franco Stevanato, Chairman and Chief Executive Officer · 2026-08-04.

Divestiture: Clearing the Path to High-Value

Consistent with this strategic focus, Stevanato completed the sale of its California-based subsidiary, Balda C. Brewer, a contract manufacturer of standard consumables and point-of-care diagnostics. CFO Marco Dal Lago explained:

“The subsidiary was expected to generate revenue of approximately EUR 30 million in fiscal year 2026 and the transaction is expected to be accretive on the full year margins.” — Marco Dal Lago, Chief Financial Officer · 2026-08-04

Though the sale resulted in €12.2 million in one-time expenses, it reinforces the company's pivot toward premium product lines and integrated solutions. This is not an isolated move; management hinted at further pruning of non-core activities, turning down the dial on bulk and standard products to free up capacity for higher-margin biologics.

Biologics: The Growth Engine

The company’s shift toward biologics is striking. Biologics now represent approximately 42% of BDS segment revenue, up from under 20% in 2022. Franco Stevanato highlighted that GLP-1s are a significant but not the only driver:

“Today, frankly speaking, the revenue inside of the BDS segment around biologics represents approximately 42%. So we moved, where in 2022, we were approximately a little bit less than 20%, today, we are more than 42%.” — Franco Stevanato, Chairman and Chief Executive Officer · 2026-08-04

While GLP-1s contribute ~22-23% of total revenue, the company is building a broader franchise across oncology, immunology, and rare disease. The ramp of Fishers and Latina is on track, with Fishers expected to reach full capacity by end-2028. Management reiterated its guidance for high single-digit BDS growth, adjusted EBITDA margin of ~26.8%, and free cash flow near breakeven.

Engineering: Steady Improvement, Cautious Optimism

The engineering segment posted a rebound in margins, with gross margin up 540 basis points year-over-year to 12%. The optimization plan is yielding results, but order intake remains cautious as sales cycles lengthen. Management is encouraged by new order wins, especially in visual inspection and assembly lines for drug delivery systems.

Prior Quarter Echoes

The current quarter's narrative aligns with prior management commentary. In the May 2026 call, CFO Marco Dal Lago noted the durability of GLP-1 demand:

“We reiterate our guidance for the year with a growth of mid-teens compared with 2025. They are predictable volumes for us in 2026 because we are largely covered by contractual commitments from our customers.” — Marco Dal Lago, Chief Financial Officer · 2026-05-07

Similarly, Lisa Miles in the same call emphasized the long-term opportunity: "we still see 70% of the market opportunity is in injectables and orals at 30%" “(same call)” — Lisa Miles, Chief Communications Officer · 2026-05-07. That confidence now has a concrete product milestone behind it.

Outlook

Stevanato is executing a clear strategic transformation—moving up the value chain from commodity glass to integrated drug delivery systems. The Alina approval is a proof point, and the Balda divestiture demonstrates discipline. With the biologics market expanding and the company’s capacity race underway, the next few quarters will be critical to watch. The stock remains well-positioned if execution stays on track.